FDA 510(k)

Porous Patella

N.º K: K212941 · 2022-01-20

SolicitanteEncore Medical, L.P. Dba Djo Surgical

Fecha de decisión2022-01-20

Código de productoMBH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Porous Patella is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical, L.P. Dba Djo Surgical. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212941. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Porous Patella?

Porous Patella is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Encore Medical, L.P. Dba Djo Surgical. The 510(k) number is K212941.

When did Porous Patella receive FDA 510(k) clearance?

Porous Patella received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212941.

Who is the listed applicant for Porous Patella?

The FDA 510(k) record lists Encore Medical, L.P. Dba Djo Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Porous Patella?

The FDA product code for Porous Patella is MBH.

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Fuente oficial

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